Pharmaceutical Quality Systems  
The most current information on Quality Systems

The following report was written by Dr. M. Jahnke on behalf of the APV News, published in "Die pharmazeutische Industrie", Issue 9/2000.

"The editor of the book entitled Pharmaceutical Quality Systems succeeded in recruiting ten competent authors from autority, university, and international pharmaceutical industry for to summarise and present their expert knowledge in Quality Systems within 12 chapters.

After presenting fundamentals and definitions of e.g. Quality, Quality Systems, and Quality Assurance experiences with Quality Systems based on the principles of GMP, ISO, and multinational pharmaceutical company are summarised. Topics such as „GMP/ISO Quality Systems for Drug Products Manufacturers“, „Quality Management Systems and GMP“ and „A Quality Manual for a Multinational Pharmaceutical Company“ should give an impression of the broad spectrum of subjects addressed.

Furthermore, aspects of the Master Plan concept, experiences and strategies for the (self-) Inspection of Quality Systems, and integration of Validation are analysed in detail and presented in a comprehensive manner.

Supplier Qualification Systems and a new trend in pharmaceutical Quality Systems, Hazard Analysis and Critical Control Points (HACCP), are described in the last chapters of the book.

The relevant national and international guidelines have been considered and each chapter gives a summary of relevant literature and recommended reading.

The reader is guided on a structured and systematic way trough 370 pages of information on various concepts of Quality Systems. For a prize of 169,-- US $ a compendium of condensed expert´s knowledge is presented that will encourage the reader to analyse the needs and strategies for the development of Quality Systems."

INTERPHARM PRESS, USA
ISBN 1-57491-104-0,
Order No.  DM-IPPQS, Price US$ 169.00

Table of Contents

Chapter 1
Introduction in Quality Systems
Oliver Schmidt, CONCEPT HEIDELBERG
Rudolf Völler, Regierungspräsidium Darmstadt

Chapter 2
Experiences in the Inspecting of Quality Systems
Rudolf Völler, Regierungspräsidium Darmstadt

Chapter 3
GMP/ISO Quality Systems for Drug Products Manufacturers
Oliver Schmidt, CONCEPT HEIDELBERG

Chapter 4
Quality Management Systems and GMP
Lothar Hartmann, Hoffmann-La Roche

Chapter 5
The Master Plan Concept: GMP-Compliant Production in a Non-GMP-Environment
Karl Metzger

Chapter 6
A Quality Manual for a Multinational Pharmaceutical Company
David F. Sullivan, Hoechst Marion Roussel AG

Chapter 7
Implementation of a Quality Assurance System into a German Pharmaceutical Company
Heinrich Prinz, Biotest AG

Chapter 8
Implementation of a Quality System: A Report of Practical Experience
Oliver Schmidt, CONCEPT HEIDELBERG

Chapter 9
Experiences in the Auditing of a Quality Assurance System: Industry's View
Andreas Brutsche, Novartis Pharma AG

Chapter 10
How to Implement Validation into a QA System
Fritz Demmer, Pharmaceutical Consultant

Chapter 11
How to build up a Supplier Qualification System
Wolfgang Schumacher, Asta Medica AG

Chapter 12
Hazard Analysis and Critical Control Points in a Pharmaceutical QA System
Michael Jahnke, Pharma Hameln GmbH